Sustaining Engineering Project Manager (Medical Device) Job at Cygnus Professionals Inc., Covington, GA

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  • Cygnus Professionals Inc.
  • Covington, GA

Job Description

  • Develop and manage project plans using MS Project / OnePlan.
  • Drive project execution from initiation through change notifications (Project Charter, ECR).
  • Manage change control and design planning through CCP/DDP/PEGA.
  • Coordinate engineering changes for Cost to Win, Line Extension, Quality Improvement, Labeling & Packaging, Supplier Validation, Regulatory Compliance.
  • Support design transfer activities and Design History File audits.
  • Oversee creation and updates of design control documents (Design Inputs, Traceability Matrix, Specifications, Verification Plans, Protocols & Reports, FMEA).
  • Gather requirements and responses from cross-functional teams.
  • Coordinate with teams for Design Verification Testing and Process Validation (IQ/OQ/PQ).
  • Manage transactions in PLM tools (MasterControl, PEGA).
  • Prepare project status reports, risk assessments, and obsolescence reports.
  • Conducting periodic Review with core team members and update the project status update to Client portfolio manager.
  • Required Skills

    • Strong Project Management skills with experience in regulated industries.
    • Basic R&D and Engineering knowledge (Mechanical/Electrical).
    • Proficiency in MS Project (MPP) and MS Office Suite.
    • Familiarity with tools like SolidWorks, AutoCAD, Minitab (statistical analysis).
    • Excellent communication and stakeholder management skills.
    • Cross-functional coordination and collaboration skills.
    • Qualifications
    • Bachelor’s degree in mechanical engineering.
    • 10+ years of experience in Project Management, preferably in Medical Devices or regulated industry.
    • Knowledge of ISO 13485 / QSR 21 CFR Part 820 is an advantage.

    Tools & Systems: MS Project, MasterControl, PEGA, OnePlan, SolidWorks, AutoCAD, Minitab

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